BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3103533 · Received May 9, 2013

    Report

    Report Number
    1525712-2013-03683
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE JOYSTICK GIMBLE NOT CONNECTING PROPERLY ON THE M51PR POWER CHAIR. THIS EVENT COULD CAUSE THE USER TO BECOME STRANDED OR IT COULD CAUSE THE CHAIR TO MAKE UNEXPECTED AND UNINTENDED MOVEMENTS, CAUSING POSSIBLE HARM TO THE USER OR BYSTANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204390 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other